Actively Recruiting
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Led by Yuvell · Updated on 2026-03-13
34
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
Sponsors
Y
Yuvell
Lead Sponsor
C
Croma-Pharma GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to learn how a perioral rejuvenation procedure affects perioral line severity and lip volume over time in adults undergoing routine aesthetic treatment in a single clinical center. The main questions it aims to answer are: * What proportion of participants achieves a ≥1-point improvement from baseline on both the Lip Fullness Scale (LFS) and the Static Perioral Lines Assessment Scale (SPLAS) at Week 12? * How do skin wrinkling/surface roughness, lip and perioral volume, and patient satisfaction change over 6 and 12 weeks? Participants will: * Receive a routine (non-study-mandated) holistic perioral rejuvenation procedure as decided by their treating clinician. * Attend study visits at approximately baseline, Week 6, and Week 12. * Undergo independent clinical assessments (assessor not involved in treatment delivery) of LFS and SPLAS. * Have skin wrinkling and surface roughness documented by VISIA skin analysis (baseline, Week 6, Week 12). * Have lip and perioral volume measured by VECTRA M3 volume analysis (baseline, Week 6, Week 12). * Complete a standardized patient satisfaction questionnaire (Week 12).
CONDITIONS
Official Title
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at time of treatment
- At least mild static perioral lines and maximum of thin lips, as assessed by the investigator
- Participant has a stable medical condition with no uncontrolled systemic disease
- Willingness to participate in the routine follow-up after 12 weeks and a signed ICF
- Participant already visiting the clinic for the specific treatment
You will not qualify if you...
- Pregnancy and breast feeding
- Known impairment of blood coagulation
- Presence of acute infection or inflammation at the proposed injection sites
- Hyaluronic Acid-Filler treatment in the perioral area within the last 6 months
- Patients with a history of autoimmune disease or who are receiving immune therapy
- History of hypersensitivity to hyaluronic acid, lidocaine hydrochloride or other amide-type local anaesthetics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
YUVELL
Vienna, State of Vienna, Austria, 1010
Actively Recruiting
Research Team
M
Mia Cajkovsky
CONTACT
M
Michelle Friedrich, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here